US FDA issued two medical devices (final guidance documents on January 26, 2022, to help sponsors better incorporate and capture patients’ experiences in medical device clinical studies.
The 1st guidance is "Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation" which describe principles that should be considered when using Patient-Reported Outcome (PRO) instruments in the evaluation of medical devices and provide recommendations about the importance of ensuring the measures are fit-for-purpose.
The 2nd guideline is "Patient Engagement in the Design and Conduct of Medical Device Clinical Studies" which is intended
To help sponsors understand how they can voluntarily use patient engagement to elicit experience, perspectives, and other relevant information from patient advisors to improve the design and conduct of medical device clinical studies;
To highlight the benefits of engaging with patient advisors early in the medical device development process
To illustrate which patient engagement activities are generally not considered by FDA to constitute research or activity subject to FDA’s regulations, including regulations regarding institutional review boards (IRBs)
To address common questions and misconceptions about collecting and submitting to FDA patient engagement information regarding the design and conduct of a medical device clinical study.